(22 days)
The Traveler™ Portal Vein Access Set is intended for transjugular liver access in diagnostic and interventional procedures.
Each Portal Vein Access Set contains a 5F MPA catheter, a puncturing tool that comes in the following variations: 0.038" Stylet with a 5Fr Stylet Catheter (separated with a removable spacer clip) or a 21ga Needle/5Fr Catheter or a 16ga Needle/7Fr Catheter (both are separated with a removable spacer clip) and a bending tool. The 14ga stiffening cannula with cannula sheath and the 16ga needle has a curved end, with a directional handle that indicates the direction of the curve.
The provided text is a 510(k) summary for the Traveler™ Portal Vein Access Set. This document is a premarket notification to the FDA, demonstrating that a new device is substantially equivalent to a legally marketed predicate device. The primary purpose of this submission is not to prove the device's efficacy through a clinical study demonstrating performance against specific acceptance criteria, but rather to show that it is as safe and effective as an existing, cleared device.
Therefore, the document does not contain information on "acceptance criteria for device performance" in the way one would typically find for a novel device requiring a clinical trial with statistical endpoints. Instead, it describes non-clinical functional and material testing to demonstrate performance parity with the predicate device after a modification (removal of two components).
Based on the provided text, here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
The document states: "Test results demonstrate that all acceptance criteria were met; therefore, the device meets the established product specifications." However, it does not provide a table detailing specific quantitative acceptance criteria or the measured performance values for each test leveraged from K201489 or for the new verification testing.
Instead, it lists the types of non-clinical tests performed:
| Type of Testing | Specific Tests Mentioned (if any) | Reported Performance / Outcome |
|---|---|---|
| New Verification Testing (due to modification) | Functional Fit | Acceptance criteria met. Device meets established product specifications. |
| Hemostasis | Acceptance criteria met. Device meets established product specifications. | |
| Leak | Acceptance criteria met. Device meets established product specifications. | |
| Simulative Use (including component compatibility) | Acceptance criteria met. Device meets established product specifications. | |
| Leveraged Performance Testing (from K201489) | Radiopacity | Acceptance criteria met. Device meets established product specifications. |
| Echogenicity | Acceptance criteria met. Device meets established product specifications. | |
| Corrosion Resistance | Acceptance criteria met. Device meets established product specifications. | |
| Dimensional & Functional Fit | Acceptance criteria met. Device meets established product specifications. | |
| Tensile Strength | Acceptance criteria met. Device meets established product specifications. | |
| Torque Strength Test | Acceptance criteria met. Device meets established product specifications. | |
| Liquid Leakage | Acceptance criteria met. Device meets established product specifications. | |
| Air Leakage | Acceptance criteria met. Device meets established product specifications. | |
| Burst Pressure | Acceptance criteria met. Device meets established product specifications. | |
| Flow Rate | Acceptance criteria met. Device meets established product specifications. | |
| Simulative Use - performance testing including dimensional, surface and compatibility of components | Acceptance criteria met. Device meets established product specifications. | |
| Luer Functional Testing | Acceptance criteria met. Device meets established product specifications. | |
| Shipping Test | Acceptance criteria met. Device meets established product specifications. | |
| Resistance to Fracture Testing | Acceptance criteria met. Device meets established product specifications. | |
| Biocompatibility Testing (leveraged from K201489) | Cytotoxicity (ISO 10993-5) | Acceptance criteria met. Device meets established product specifications. |
| Sensitization (ISO 10993-10) | Acceptance criteria met. Device meets established product specifications. | |
| Intracutaneous Irritation (ISO 10993-10) | Acceptance criteria met. Device meets established product specifications. | |
| Acute Systemic Toxicity (ISO 10993-11) | Acceptance criteria met. Device meets established product specifications. | |
| Material Mediated Pyrogen (ISO 10993-11) | Acceptance criteria met. Device meets established product specifications. | |
| Hemocompatibility (ISO10993-4): ASTM Hemolysis – Direct and Indirect Contact, Complement Activation, SC5b-9, In Vivo Thrombogenicity, Platelet and Leucocyte counts, Partial Thromboplastin Time (PTT) | Acceptance criteria met. Device meets established product specifications. |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document lists only non-clinical (bench) and biocompatibility testing. It does not specify sample sizes for these tests. It also does not mention any clinical data, human subjects, or data provenance (country of origin, retrospective/prospective), as clinical testing was not required.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This document pertains to a 510(k) submission for a device modification, where substantial equivalence is demonstrated through non-clinical testing. There is no mention of human experts (e.g., radiologists) or ground truth establishment relevant to an AI/imaging device validation. The "ground truth" here would be defined by the specifications and standards for the mechanical and biological properties of the device, assessed through laboratory testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This document describes non-clinical and biocompatibility testing of a medical device, not a human reader study or AI performance evaluation where adjudication methods would be used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This submission is for a physical medical device (catheter introducer) and its modification, not an AI/imaging device that would perform a MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This submission is for a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this type of device and submission, the "ground truth" for the non-clinical tests is established by engineering specifications, international and national standards (e.g., ISO, ASTM), and validated test methods. Compliance with these predefined specifications and standards serves as the "ground truth" for demonstrating that the device meets its design requirements.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" as this is not an AI/machine learning device.
In summary: The provided document is a 510(k) summary for a Class II medical device (catheter introducer) that has undergone a minor modification. The demonstration of safety and effectiveness relies on non-clinical (bench) and biocompatibility testing, leveraging data from the predicate device and adding specific tests for the modified components. It does not involve AI, clinical trials, or human evaluations as would be the case for AI-based medical devices. Therefore, many of the requested points related to AI/human reader studies are not present in this document.
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December 10, 2021
Argon Medical Devices Ana Jimenez-Hughes Senior Regulatory Affairs Specialist 1445 Flat Creek Road Athens, Texas 75751
Re: K213638
Trade/Device Name: Traveler 0.038" Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003) Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: November 17, 2021 Received: November 18, 2021
Dear Ana Jimenez-Hughes:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Misti Malone, PhD Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213638
Device Name Traveler™ Portal Vein Access Set
Indications for Use (Describe)
The Traveler™ Portal Vein Access Set is intended for transjugular liver access in diagnostic and interventional procedures
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Date Prepared: November 17, 2021
| Company: | Argon Medical Devices, Inc.1445 Flat Creek RoadAthens, Texas 75751 USAFacility Registration number: 1625425 |
|---|---|
| Contact: | Ana Jimenez-HughesSenior Regulatory Affairs SpecialistPhone: 903-676-4276Fax: 903-677-9396Email: ana.hughes@argonmedical.com |
| Device TradeName: | Traveler™ Portal Vein Access Set |
| DeviceCommonName: | Catheter Introducer |
| DeviceClassification: | Introducer, CatheterProduct code, DYB21 CFR 870.1340Class IIReview Panel: Cardiovascular Devices |
| PredicateDevice(s): | Primary: K201489 Traveler™ Portal Vein Access Set |
| Description ofthe Device: | Each Portal Vein Access Set contains a 5F MPA catheter, a puncturing tool that comesin the following variations: 0.038" Stylet with a 5Fr Stylet Catheter (separated with aremovable spacer clip) or a 21ga Needle/5Fr Catheter or a 16ga Needle/7Fr Catheter(both are separated with a removable spacer clip) and a bending tool. The 14gastiffening cannula with cannula sheath and the 16ga needle has a curved end, with adirectional handle that indicates the direction of the curve. |
| Indication forUse: | The Traveler™ Portal Vein Access Set is intended for transjugular liver access indiagnostic and interventional procedures. |
| Device Modification: | The device modification included in this submission is limited to the removal of the following components from the Traveler™ 0.038" Stylet Portal Vein Access Set, the Traveler™ 21 ga Needle Portal Vein Access Set, and the Traveler™ 16 ga Needle Portal Vein Access Set:10F Introducer sheath 10F Dilator |
| Substantial Equivalence: | There is no change of intended use or fundamental scientific technology between the proposed modified and predicate device. The proposed modified device has the same indication for use as the predicate, K201489. |
| Non-Clinical TestingIn accordance with the Design Failure Modes and Effects Analysis, verification testing was identified to support the substantial equivalence of the modified Traveler Portal Vein Access Set. The tests included: Functional Fit Hemostasis Leak Simulative Use (including component compatibility) The following testing was leveraged from K201489: Performance Testing: Radiopacity Echogenicity Corrosion Resistance Dimensional & Functional Fit Tensile Strength Torque Strength Test Liquid Leakage Air Leakage Burst Pressure Flow Rate Simulative Use - performance testing including dimensional, surface and compatibility of components Luer Functional Testing Shipping Test Resistance to Fracture Testing Biocompatibility Cytotoxicity (ISO 10993-5) Sensitization (ISO 10993-10) Intracutaneous Irritation (ISO 10993-10) Acute Systemic Toxicity (ISO 10993-11) |
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- Material Mediated Pyrogen (ISO 10993-11) O
- o Hemocompatibility (ISO10993-4)
- ASTM Hemolysis – Direct and Indirect Contact
- 트 Complement Activation, SC5b-9
- 트 In Vivo Thrombogenicity
- ' Platelet and Leucocyte counts
- . Partial Thromboplastin Time (PTT)
Animal testing was not required for the determination of substantial equivalence.
Clinical testing was not required for the determination of substantial equivalence.
Test results demonstrate that all acceptance criteria were met; therefore, the device meets the established product specifications.
Conclusion: The proposed device modifications to the Traveler™ Portal Vein Access Set do not change its intended use or principles of operation. Based on the Indication for Use, design, and safety and performance testing, the Traveler™ Portal Vein Access Set meets the requirements for its intended use and is substantially equivalent to the predicate device.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).